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Clinical Trials in the USA / NCT05870488
Active, not recruiting Phase 4

iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction

NCT05870488 · tracked via the Priya Life Science USA tracker
Sponsor
SI-BONE, Inc.
Phase
Phase 4
Started
2023-05-23
Last updated
2026-08-06

Condition(s) studied

Sacroiliac Joint DysfunctionSacroiliac; FusionSacroiliac DisorderSacroiliac Joint Pain

Investigational drug(s) / intervention(s)

Use of iFuse TORQ

Use of iFuse TORQ: Use of iFuse TORQ for the treatment of SI Joint dysfunction

Study summary

iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction (STACI) is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system.

Eligibility

Sex
ALL
Min age
21 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age \> 21 at time of screening 2. Patient has lower back / buttock pain for at least 6 months inadequately responsive to non-surgical care 3. Diagnosis of sacroiliac joint dysfunction (degenerative sacroiliitis or sacroiliac disruption) 4. Baseline Oswestry Disability Index (ODI) score of at least 30% 5. Baseline SIJ pain score of at least 5 on 0-10 numerical rating scale 6. BMI \< 35 7. Patient has signed study-specific informed consent form Exclusion Criteria: 1. ASA score 4 or 5 2. Severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture 3. Other known sacroiliac pathology such as: inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy), tumor, infection, acute fracture 4. Cluneal neuralgia 5. Previous SIJ implant placement, including allograft 6. Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable device placement 7. History of recent (\<1 year) major trauma to pelvis 8. Previously diagnosed or suspected severe osteoporosis (defined as prior T-score \< -2.5 or history of osteoporotic fracture). 9. Chronic rheumatologic condition (e.g., rheumatoid arthritis) 10. Current diagnosis of fibromyalgia 11. Known allergy to titanium or titanium alloys 12. Current local or systemic infection that raises the risk of surgery 13. Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation 14. Currently pregnant or planning pregnancy in the next 2 years (self-reported) 15. Patient is a prisoner or a ward of the state. 16. Known or suspected active drug or alcohol abuse, including opioids 17. Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation 18. Currently participating in another interventional clinical trial

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
Napa Valley Orthopaedics Napa California
Source Healthcare Santa Monica California
Comprehensive Pain and Spine Specialists Shelbyville Indiana
Ascentist Healthcare Leawood Kansas
Crimson Pain Management Overland Park Kansas
University of Kentucky Lexington Kentucky
Clearway Pain Annapolis Maryland
St Louis Pain Consultants Chesterfield Missouri
Nevada Advanced Pain Reno Nevada
Clinical Investigations Edmond Oklahoma
Neurological Associates of Lancaster Lancaster Pennsylvania
Advanced Pain Institute of Texas Lewisville Texas
Anesis Spine & Pain Care Renton Washington
Pro Spine and Pain Milwaukee Wisconsin

More SI-BONE, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05870488 on ClinicalTrials.gov ↗ ← All trials in the USA